Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016848
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-06-06
Brief Title:
Effects of Dietary Carbohydrate and Fat on Hormones
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects of Dietary Carbohydrate and Fat on Hormone Regulators of Body Composition and Reproduction
Status:
COMPLETED
Status Verified Date:
2003-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will try to determine if intake of dietary fats or carbohydrates influences the tendency to gain weight or accumulate body fat It will examine how the hormones that regulate weight may change with a shift from a balanced diet to one that is low in fat or carbohydrate irrespective of caloric intake
Men and women between the ages of 18 and 40 years with a body mass index of 30 to 49 kgm2 may be eligible for this study Candidates will be screened with a history physical examination blood tests and questionnaires regarding activity prior diets and eating patterns
Participants will follow two separate diet regimens for 5 days each The first will be a balanced diet and the second will be either a low-fathigh-carbohydrate diet or a low-carbohydratehigh-fat diet The diets are not designed to produce weight loss Participants will receive all their meals and snacks for the two diets from the National Institutes of Health and for the first 3 days of each diet will be seen as outpatients For days 4 and 5 of each diet they will be admitted to the Clinical Center and will undergo the following procedures
Blood tests - Blood samples will be collected every 30 minutes over a 24-hour period through an indwelling catheter in the arm A total of about 15 tablespoons will be drawn for each of the two diets
24-hour urine collection - One 24 hour urine collection will be done at home the day before admission to the Clinical Center and the other will be done during the hospital stay
Urinalysis and pregnancy test - A small urine sample will be taken and women will provide an additional sample for a pregnancy test
Body measurements - Height and weight will be measured using scales Body fat will be measured by two methods skin fold thickness measured with calipers in 5 separate places and body circumference measurements in which body parts are measured with a tape measure
Bod pod measurement - Proportions of fat and non-fat tissue in body weight are measured while the participant sits in a capsule-like device for 5 minutes
Bioelectric impedance analysis - Proportions of body fat are measured based on conduction of a small electric current
Total body water estimate -The proportion of body weight that is water is determined using a method that involves drinking a cup of a special kind of heavy water deuterium and then measuring the amount of heavy water in a urine sample taken after 4 hours
Exercise - Participants will maintain their usual exercise routine as it was before beginning the study
Men and women between the ages of 18 and 40 years with a body mass index of 30 to 49 kgm2 may be eligible for this study Candidates will be screened with a history physical examination blood tests and questionnaires regarding activity prior diets and eating patterns
Participants will follow two separate diet regimens for 5 days each The first will be a balanced diet and the second will be either a low-fathigh-carbohydrate diet or a low-carbohydratehigh-fat diet The diets are not designed to produce weight loss Participants will receive all their meals and snacks for the two diets from the National Institutes of Health and for the first 3 days of each diet will be seen as outpatients For days 4 and 5 of each diet they will be admitted to the Clinical Center and will undergo the following procedures
Blood tests - Blood samples will be collected every 30 minutes over a 24-hour period through an indwelling catheter in the arm A total of about 15 tablespoons will be drawn for each of the two diets
24-hour urine collection - One 24 hour urine collection will be done at home the day before admission to the Clinical Center and the other will be done during the hospital stay
Urinalysis and pregnancy test - A small urine sample will be taken and women will provide an additional sample for a pregnancy test
Body measurements - Height and weight will be measured using scales Body fat will be measured by two methods skin fold thickness measured with calipers in 5 separate places and body circumference measurements in which body parts are measured with a tape measure
Bod pod measurement - Proportions of fat and non-fat tissue in body weight are measured while the participant sits in a capsule-like device for 5 minutes
Bioelectric impedance analysis - Proportions of body fat are measured based on conduction of a small electric current
Total body water estimate -The proportion of body weight that is water is determined using a method that involves drinking a cup of a special kind of heavy water deuterium and then measuring the amount of heavy water in a urine sample taken after 4 hours
Exercise - Participants will maintain their usual exercise routine as it was before beginning the study
Detailed Description:
Caloric restriction triggers a number of homeostatic endocrine responses including suppression of leptin gonadotropins sex steroids thyroid hormones insulin and insulin like growth factors IGFs and elevation of growth hormone GH and cortisol Some of these effects may be disadvantageous in terms of achieving loss of adipose tissue There is little information on the role of specific macronutrients in the regulation of these important endocrine responses to food restriction The present study aims to determine if dietary carbohydrate andor lipid composition has significant effects on these hormonal regulators of body composition and metabolism independent of total calorie supply This will be achieved by comparing the short-term effects of isocaloric weight maintenance diets restricted in either fat or carbohydrate with a standard balanced diet Protein contribution as well as calorie content will be held constant in the 3 diets Study subjects will be obese women and men BMI 30-349 kgm2 aged 18-40 years Major study outcome parameters include leptin gonadotropin GH and cortisol secretory dynamics sex steroid IGF fasting insulin and glucose levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-CH-0183 | None | None | None |